The Role of PTH in Low Bone Mass in Anorexia Nervosa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percent Change in Lumbar Spine Bone Mineral Density
研究概览
简要总结
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.
We are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.
详细描述
Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a number of significant medical conditions including bone loss. A majority of women with anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2 standard deviations below normative means. Bone loss in anorexia nervosa is characterized by a decrease in bone formation, therefore therapy with an anabolic agent may be an effective treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density (primary outcome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anorexia Nervosa
- •Women, age 30-70 years
- •Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)
排除标准
- •Diseases known to affect bone metabolism
- •Hyperparathyroidism
- •Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year)
- •Pregnant and/or breastfeeding
- •Diabetes mellitus
- •History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone
- •Fractures of a bone other than a finger or toe in last 1 year
研究组 & 干预措施
Teriparatide
干预措施: Teriparatide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Lumbar Spine Bone Mineral Density
时间窗: Baseline and 6 months
Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)
次要结局
未报告次要终点
研究者
Pouneh K. Fazeli, MD
Assistant Professor of Medicine
Massachusetts General Hospital